BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    IMAGEN RESPIRATORY SCREEN

    K Number: K973954 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    74

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    Basic Information

    Device Name
    IMAGEN RESPIRATORY SCREEN
    K Number
    K973954
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3330
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dako Diagnostics , Ltd.
    Date Received
    October 9, 1997
    Decision Date
    December 22, 1997
    Product Code
    GNW
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GNW Antisera, Cf, Influenza Virus A, B, C

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    Other Clearances by Dako Diagnostics , Ltd.

    K Number Device Name
    K981226 IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
    K962037 IMAGEN RESPIRATORY SCREEN
    K940564 IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
    K943557 IMAGEN
    K932384 IDEIA(TM) ROTAVIRUS